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FDA approves Luminex's new assay to detect major respiratory pathogens

Published 04 August 2016

The US Food and Drug Administration (FDA) has approved Luminex's new molecular test to detect and differentiate influenza A/B and respiratory syncytial virus (RSV).

The FDA clearance for the ARIES Flu A/B & RSV assay is the second assay the agency approved for use on the Luminex ARIES system.

Aries systems are sample to answer molecular diagnostic systems, which uses internal barcode scanning and other advanced features to minimize operator errors.

The new assay is claimed to provide results in less than two hours by detecting and differentiating three respiratory pathogens such as influenza A virus, influenza B virus and respiratory syncytial virus (RSV) through sample to answer platform.

The test will detect and differentiate these viruses from nasopharyngeal swab (NPS) specimens of patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.

According to the company, the new assay enables panel customization with the unique ability to only report the results of interest.  

Luminex president and CEO Nachum Homi Shamir said: "In the battles clinicians wage to fight infectious disease, accurate and quickly actionable diagnostic test results are critical for success.

“The Aries Flu A/B & RSV Assay requires very limited hands-on time that accelerates the time to result and provides for increased accuracy.”

The company has also obtained FDA clearance for the Aries HSV 1&2 assay for use on the Aries systems.

In addition, the HSV 1&2 and Flu A/B & RSV assays have secured CE-IVD status under the European directive on in vitro diagnostic medical devices.


Image: The Aries Flu A/B & RSV assay provides results in less than two hours. Photo: courtesy of Luminex Corporation.